A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

NCT ID: NCT05820672

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-20

Study Completion Date

2033-03-31

Brief Summary

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The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

Detailed Description

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Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.

Conditions

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Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on SKYTROFA Treatment

Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are on treatment with SKYTROFA (lonapegsomatropin)
* Patients being clinically managed in USA
* Patients with an appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria

* Patients participating in any interventional clinical study
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascendis Pharma Endocrinology Division A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus Strange

Role: STUDY_DIRECTOR

Ascendis Pharma A/S

Locations

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Ascendis Investigational Site

Phoenix, Arizona, United States

Site Status RECRUITING

Ascendis Investigational Site

Sacramento, California, United States

Site Status RECRUITING

Ascendis Investigational Site

San Francisco, California, United States

Site Status RECRUITING

Ascendis Pharma Investigational Site

Centennial, Colorado, United States

Site Status RECRUITING

Ascendis Investigational Site

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Ascendis Investigational Site

Orlando, Florida, United States

Site Status RECRUITING

Ascendis Investigational Site

Orlando, Florida, United States

Site Status RECRUITING

Ascendis Investigational Site

Tampa, Florida, United States

Site Status RECRUITING

Ascendis Investigational Site

Sandy Springs, Georgia, United States

Site Status RECRUITING

Ascendis Investigational Site

Boise, Idaho, United States

Site Status RECRUITING

Ascendis Investigational Site

Indianapolis, Indiana, United States

Site Status RECRUITING

Ascendis Investigational Site

Iowa City, Iowa, United States

Site Status RECRUITING

Ascendis Investigational Site

Louisville, Kentucky, United States

Site Status RECRUITING

Ascendis Investigational Site

Minneapolis, Minnesota, United States

Site Status RECRUITING

Ascendis Investigational Site

Las Vegas, Nevada, United States

Site Status RECRUITING

Ascendis Investigational Site

Lebanon, New Hampshire, United States

Site Status RECRUITING

Ascendis Investigational Site

Morristown, New Jersey, United States

Site Status RECRUITING

Ascendis Investigational Site

New Brunswick, New Jersey, United States

Site Status RECRUITING

Ascendis Investigational Site

New Hyde Park, New York, United States

Site Status RECRUITING

Ascendis Investigational Site

Portland, Oregon, United States

Site Status RECRUITING

Ascendis Investigational Site

Columbia, South Carolina, United States

Site Status RECRUITING

Ascendis Investigational Site

El Paso, Texas, United States

Site Status RECRUITING

Ascendis Investigational Site

Norfolk, Virginia, United States

Site Status RECRUITING

Ascendis Investigational Site

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deborah Bowlby

Role: CONTACT

+1 844-442-7236

Other Identifiers

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ASND0037

Identifier Type: -

Identifier Source: org_study_id

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